<p>The United States Drug Enforcement Administration and Prescription Opioid Production Quotas: An End Game of Eradication?</p>

Abstract

As a means of mitigating the now concluded prescription opioid crisis in the United States, the Drug Enforcement Administration (DEA) has, in its infinite wisdom, embarked on a campaign of annually reducing the Aggregate Production Quota (APQ) of opioids each year since 2017. According to the DEA, they began reducing the APQ because there was no longer the need for a 25% "buffer" of excess opioids due to decreases in prescribing each year. 1 In 2017, production of almost every opioid manufactured in the United States was reduced by at least 25%. 1 In 2018, APQs of opioids-including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, meperidine, and fentanyl-were reduced by 20% compared to 2017 production. 2 For 2019, DEA reduced APQs only of "more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl". 3 The 2020 production decreases affected 5 commonly-used opioids: Oxycodone production was decreased by 9%, hydrocodone by 19%, hydromorphone by 25%, fentanyl by 31%, and oxymorphone by 55%. 4 Given, in response to the need for increased availability of opioids associated with the COVID-19 crisis, DEA made small adjustments (increases of 10-15%) in production APQs in April of 2020 of analgesics including codeine, fentanyl, hydromorphone, and morphine. 5 Unfortunately, this action was too little, too late. Hospitals that had already been sounding the alarm for the past several years regarding routine shortages of parenteral opioids suddenly were faced with inadequate supplies essential for treating patients on ventilators amidst COVID-19, with the need for IV formulations increasing more than twofold. 6 By 2020, DEA reported that total domestic opioid production had decreased by 53% since 2016. 4 Irrespective, DEA recently released its proposed production decreases for 2021, which include an additional 20% reduction of fentanyl, a 15% reduction of oxycodone, a 12% decrease of hydrocodone, and a 9% reduction of hydromorphone, all compared to the original figures for 2020. Curiously, the proposed APQ of oxymorphone actually increased by 13% compared to the original APQ for 2020, keeping its level of production unchanged from the April, 2020 adjustment. 7 This most recent proposed APQ is bewildering, given that half a year ago, DEA felt compelled to adjust its APQs in response to a pandemic which is hardly over, with no certainty regarding the course that it will take. While April's manufacturing increase may have provided a temporary fix, concern has been raised

Best Practices from the American Society of Pain and Neuroscience (ASPN) for Clinical Research During a Pandemic or Emergency

“…Study materials, including the required devices or drugs, may be inaccessible due to disruption of the supply chain. For example, research on parenteral opioids in cancer pain, already presenting a challenge due to reductions in DEA production quotas, 34 may be exacerbated due to pandemic-related supply chain issues. In these instances, the safety and health of the patient participants remains the primary objective.…”

<p>The Repeal of the Affordable Care Act and Its Likely Impact on Chronic Pain Patients: “Have You No Shame?”</p>

“…2 For a number of years, we have been writing about the urgent need to improve the deteriorating quality of pain management in the United States. [3][4][5][6] Many patients believe that the war on prescription opioids, patients who rely upon them, and physicians with the audacity to still prescribe them has resulted in the marginalization of the nation's pain care system. [7][8][9][10][11] However, the looming potential demise of the ACA based purely on political motivations and characterological flaws presents an existential threat of colossal proportions to chronic pain patients.…”